Status:
UNKNOWN
LIFT-plug vs LIFT, a RCT Trial
Lead Sponsor:
Zhen Jun Wang
Collaborating Sponsors:
The Second Artillery General Hospital
Peking University Third Hospital
Conditions:
Anal Fistula
LIFT-plug
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers
Detailed Description
The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recur...
Eligibility Criteria
Inclusion
- High transsphincteric fistula (involving \> 30% of the external anal sphincter)
- Age between 18 and 70 years
- Chronic anal fistula with fistula tracts no more than 2
- No active sepsis or abscess
Exclusion
- Fistulas with active inflammation or purulence
- Fistulas related to tumor, Crohn's disease, tuberculosis or acquired immune deficiency syndrome
- Poorly controlled diabetes with fasting blood-glucose \> 8mmol/L
- Preexisting incontinence
- Multiple fistula tracts \> 2
- Fasting blood-glucose ≥ 8mmol/L
- Allergic or contraindication for the use of animal protein
- Pregnant women
- Expected life less than 6 months
- With anorectal abscess
- Serious liver (Child-Pugh C) and chronic kidney disease (CKD) stage 3
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT04310800
Start Date
January 1 2018
End Date
December 31 2020
Last Update
March 17 2020
Active Locations (7)
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1
Beijing Anorectal Hospital
Beijing, Beijing Municipality, China, 100000
2
Beijing Luhe Hospital
Beijing, Beijing Municipality, China, 100000
3
Beijing shunyi district hospital
Beijing, Beijing Municipality, China, 100000
4
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000